Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

About this trial

This is an interventional treatment trial for Postoperative Atelectasis focused on measuring lung protective ventilation strategy, individualized positive end-expiratory pressure, Laparoscopic bariatric surgery, Mechanical ventilation, Anesthetic management, Lung dynamic compliance, Postoperative Atelectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Bmi ≥ 35 kg/ m2
over 18 years old
elective laparoscopic bariatric surgery (gastric bypass or sleeve)

Exclusion Criteria:

ASA >IV
Lung bullae
thoracic surgery history
quit smoking less than 1 week
chronic obstructive pulmonary disease requiring oxygen
congestive heart failure (New York Heart Association classification ≥ III)
planned to be transferred to intensive care unit after surgery
Patients participating in another interventional study
Refuse to sign the informed consent

Sites / Locations

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

individualized PEEP

PEEP 8

Arm Description

Basic ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized, the PEEP was then maintained (individualized PEEP arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Bacis ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized , the PEEP was then reduced to 8cm H2O (PEEP8 arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Outcomes

Primary Outcome Measures

Percentage of postoperative atelectasis

The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.

Secondary Outcome Measures

pulse oxygen

Continuous measurement of 24h pulse oxygen after surgery（%）

PaO2/FiO2 ratio

Quality of Recovery Score - 40 (QoR-40)

Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).

Mini-Mental score examination (MMSE)

Mini-Mental score examination [MMSE] used for screening of dementia.The total score on the MMSE ranges from 0 (most severe dementia) to 24 (no dementia).

Postoperative Complication

including pulmonary and other systematic postoperative complications

Mean arterial pressure

Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）

systolic blood pressure

systolic blood pressure measured by invasive arterial blood pressure（mmHg）

diastolic blood pressure

diastolic blood pressure measured by invasive arterial blood pressure（mmHg）

heart rate

heart rate per minute

pulse oxygen

pulse oxygen（%）

dynamic compliance

tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）

airway plateau pressure

airway plateau pressure is directly showed in the screen of ventilator（cmH2O）

airway peak pressure

airway peak pressure is directly showed in the screen of ventilator（cmH2O）

Full Information

NCT ID

NCT04169607

First Posted

October 13, 2019

Last Updated

July 19, 2021

Sponsor

Xuzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04169607

Brief Title

Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery

Official Title

Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery: a Single-center, Double-blind Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

July 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

This study intends to explore the effect of dynamic compliance guided individualized positive end-expiratory pressure titration strategy on reducing the level of postoperative atelectasis in obese patient who have laparoscopic bariatric surgery.The results of the study are to assess the effects of this intervention on the incidence，duration of postoperative atelectasis and other complications including hypoxemia etc. after laparoscopic bariatric surgery.And reducing the burden of postoperative atelectasis on patients and their families, hospitals and public resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Atelectasis

Keywords

lung protective ventilation strategy, individualized positive end-expiratory pressure, Laparoscopic bariatric surgery, Mechanical ventilation, Anesthetic management, Lung dynamic compliance, Postoperative Atelectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

individualized PEEP

Arm Type

Experimental

Arm Description

Basic ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized, the PEEP was then maintained (individualized PEEP arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Arm Title

PEEP 8

Arm Type

Active Comparator

Arm Description

Bacis ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized , the PEEP was then reduced to 8cm H2O (PEEP8 arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Intervention Type

Procedure

Intervention Name(s)

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Intervention Description

Basic ventilation: Volume-controlled ventilation (VCV) mode with positive end-expiratory pressure (PEEP) of 8cm H2O after induction of anesthesia， Recruitment maneuver (RM): Pressure-controlled ventilation (PCV) mode increasing PEEP from 10 to 25cmH2O in step of 5cmH2O per 30s. PEEP-titration maneuver: ventilation parameters reset as basic ventilation with PEEP still 25cmH2O.Decrease PEEP to 5cmH2O in step of 2cmH2O per 10 respiratory cycles to confirm the highest dynamic lung compliance (Cdy). After titration: A new RM will be performed and the final PEEP will be the one related to highest Cdy plus 2cm H2O. Randomized after the second RM. Individualized PEEP arm: maintain individualized PEEP; PEEP8 arm: maintain a fixed PEEP of 8cm H2O. VCV with other ventilation parameters the same as basic ventilation until extubation . After discharged from postoperative anesthesia care unit (60 to 90 minutes after extubation): chest CT .

Primary Outcome Measure Information:

Title

Percentage of postoperative atelectasis

Description

The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.

Time Frame

60-90 minutes after extubation

Secondary Outcome Measure Information:

Title

pulse oxygen

Description

Continuous measurement of 24h pulse oxygen after surgery（%）

Time Frame

24 hours after surgery

Title

PaO2/FiO2 ratio

Description

PaO2/FiO2 ratio

Time Frame

1 day before surgery(baseline)，5 minutes after anesthesia induction，1 hour after pneumoperitoneum，before extubation，30 minutes after extubation

Title

Quality of Recovery Score - 40 (QoR-40)

Description

Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).

Time Frame

1 day before surgery(baseline)，1，2，7，30 days after surgery

Title

Mini-Mental score examination (MMSE)

Description

Mini-Mental score examination [MMSE] used for screening of dementia.The total score on the MMSE ranges from 0 (most severe dementia) to 24 (no dementia).

Time Frame

1 day before surgery(baseline)，1，2 days after surgery

Title

Postoperative Complication

Description

including pulmonary and other systematic postoperative complications

Time Frame

1，2，7 days after surgery

Title

Mean arterial pressure

Description

Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）

Time Frame